Quality Systems

Accelerating Clinical Trials in the EU

September 02, 2023

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Clinical Trials and their Impact on the Pharma Industry

September 02, 2023

There are many promising trials in the pipeline that may bring big news for major therapeutic areas.

Clearing Up Confusion in Inspection Terminology

September 02, 2023

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

White House Sets Medicare Price Negotiation Targets

August 31, 2023

The Centers for Medicare & Medicaid Services (CMS) has announced the first 10 drugs covered under Medicare Part D selected for negotiation.

FDA Approves Bristol Myers Squibb Anemia Treatment

August 31, 2023

Bristol Myers Squibb’s Reblozyl (luspatercept-aamt) is approved as a first-line treatment for anemia in adults with lower-risk myelodysplastic syndromes.

Pfizer and BioNTech Get Positive Opinion in Europe for Omicron XBB.1.5-adapted COVID-19 Vaccine

August 31, 2023

The updated vaccine will be ready to ship following a positive European Commission review.

FDA Approves Biosimilar to Treat Multiple Sclerosis

August 30, 2023

This is the first biosimilar to Tysabri, an injection for adults with multiple sclerosis.

Discussing the State of Pharma with Congressman Adam Smith

August 25, 2023

Adam Smith, a House of Representatives member representing Washington's 9th congressional district, discusses the state of U.S. healthcare and pharma.

Alterity Therapeutics Given European Composition of Matter Patent for Neurodegenerative Diseases

August 24, 2023

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

Regeneron Gets FDA Approvals on New Biologic and New High Dose for Eye Disease Therapy

August 23, 2023

FDA has approved a new mAb therapy from Regeneron Pharmaceuticals as well as a higher dose version of Eylea, the company’s eye disease therapeutic.